74% of continuously-treated patients with a
blood eosinophil count 300 or greater were exacerbation-free in the
second year of treatment
Data presented at the European Respiratory
Society (ERS) International Congress 2018
AstraZeneca today announced results from the Phase III extension
BORA trial evaluating the long-term safety and efficacy of FASENRA™
(benralizumab) as an add-on maintenance treatment in patients with
severe eosinophilic asthma who had previously completed one of the
two pivotal SIROCCO or CALIMA Phase III trials.
In the BORA trial, FASENRA given for an additional 56 weeks
showed a safety and tolerability profile similar to that observed
in the placebo-controlled SIROCCO and CALIMA trials, with no
increase in the frequencies of overall or serious adverse events.
The improvements in efficacy measures observed with FASENRA in the
SIROCCO or CALIMA trials were maintained over the second year of
treatment. Patients who were treated with placebo in the SIROCCO
and CALIMA trials and subsequently transitioned to FASENRA in the
BORA trial experienced improvements in efficacy outcomes consistent
with those observed for FASENRA-treated patients in the previous
trials. FASENRA is not approved for the treatment of other
eosinophilic conditions or relief of acute bronchospasm or status
asthmaticus.
74% of patients with a baseline blood eosinophil count of 300
cells per μL or greater (the primary efficacy population in the
Phase III trials) who received FASENRA every eight weeks
continuously from SIROCCO or CALIMA and into BORA, were
exacerbation-free in BORA in their second year of treatment and
maintained improvements in lung function and asthma control.
65% and 66%, respectively, of patients with a baseline blood
eosinophil count of 300 cells per μL or greater who received
FASENRA 30 mg every eight weeks were exacerbation-free their first
year of treatment in the one-year, predecessor SIROCCO and CALIMA
trials (49% for placebo arms in both trials).
The BORA data will be presented today during a late-breaking
oral session at the European Respiratory Society (ERS)
International Congress 2018 in Paris, France.
Sean Bohen, Executive Vice President, Global Medicines
Development and Chief Medical Officer, said: “The BORA data are
important news for patients with severe eosinophilic asthma who
need a treatment with sustained efficacy to help control their
disease, and with a safety profile that supports long-term
use.”
Dr. William Busse, Professor of Medicine, Division of Allergy,
Pulmonary and Critical Care Medicine, University of Wisconsin
School of Medicine and Public Health, and lead investigator on
BORA, said: “As a clinician, I am excited by the BORA trial
results, which provide confidence to patients with severe
eosinophilic asthma and physicians that the positive outcomes they
are seeing with FASENRA can be maintained over a second year of
treatment. In FASENRA, we have a biologic treatment that can
improve outcomes for these patients long-term.”
The overall annual asthma exacerbation rate for patients with
baseline blood eosinophil counts of 300 cells per μL or greater who
received FASENRA every 8 weeks continuously was consistent with the
predecessor SIROCCO and CALIMA trials (0.46 in BORA; 0.65 and 0.66
in SIROCCO and CALIMA, respectively). Overall improvements in lung
function, asthma control, asthma-related and general health-related
quality of life scores were maintained for patients who received
FASENRA continuously and were improved for patients previously
receiving placebo in SIROCCO or CALIMA. Near complete eosinophil
depletion was maintained in patients who continuously received
FASENRA.
The most commonly-reported adverse events (≥ 5%) in BORA were
upper respiratory tract infection, worsening asthma, headache,
bronchitis and acute sinusitis. The most commonly-reported adverse
events in SIROCCO, CALIMA and ZONDA (≥ 5%) were headache and
pharyngitis.
FASENRA is AstraZeneca’s first respiratory biologic and is
approved as an add-on maintenance treatment for severe eosinophilic
asthma in the US, EU, Japan and several other countries.
IMPORTANT SAFETY INFORMATION
CONTRAINDICATIONS
Known hypersensitivity to benralizumab or excipients.
WARNINGS AND PRECAUTIONS
Hypersensitivity Reactions
Hypersensitivity reactions (eg, anaphylaxis, angioedema,
urticaria, rash) have occurred after administration of FASENRA.
These reactions generally occur within hours of administration, but
in some instances have a delayed onset (ie, days). Discontinue in
the event of a hypersensitivity reaction.
Acute Asthma Symptoms or Deteriorating Disease
FASENRA should not be used to treat acute asthma symptoms, acute
exacerbations, or acute bronchospasm.
Reduction of Corticosteroid Dosage
Do not discontinue systemic or inhaled corticosteroids abruptly
upon initiation of therapy with FASENRA. Reductions in
corticosteroid dose, if appropriate, should be gradual and
performed under the direct supervision of a physician. Reduction in
corticosteroid dose may be associated with systemic withdrawal
symptoms and/or unmask conditions previously suppressed by systemic
corticosteroid therapy.
Parasitic (Helminth) Infection
It is unknown if FASENRA will influence a patient’s response
against helminth infections. Treat patients with pre-existing
helminth infections before initiating therapy with FASENRA. If
patients become infected while receiving FASENRA and do not respond
to anti-helminth treatment, discontinue FASENRA until infection
resolves.
ADVERSE REACTIONS
The most common adverse reactions (incidence > to 5%) include
headache and pharyngitis. Injection site reactions (e.g., pain,
erythema, pruritus, papule) occurred at a rate of 2.2% in patients
treated with FASENRA compared with 1.9% in patients treated with
placebo.
USE IN SPECIFIC POPULATIONS
The data on pregnancy exposure from the clinical trials are
insufficient to inform on drug-associated risk. Monoclonal
antibodies such as benralizumab are transported across the placenta
during the third trimester of pregnancy; therefore, potential
effects on a fetus are likely to be greater during the third
trimester of pregnancy.
INDICATION
FASENRA is indicated for the add-on maintenance treatment of
patients with severe asthma aged 12 years and older, and with an
eosinophilic phenotype.
- FASENRA is not indicated for treatment
of other eosinophilic conditions
- FASENRA is not indicated for the relief
of acute bronchospasm or status asthmaticus
Please read full Prescribing Information,
including Patient Information.
You are encouraged to report negative side effects of
prescription drugs to the FDA.
Visit www.FDA.gov/medwatch or
call 1-800-FDA-1088.
NOTES TO EDITORS
About Severe Asthma
Asthma affects approximately 26 million individuals in the US.
Up to 10% of asthma patients have severe asthma, which may be
uncontrolled despite high doses of standard-of-care asthma
controller medicines and can require the use of chronic oral
corticosteroids (OCS). Severe, uncontrolled asthma is debilitating
and potentially fatal with patients experiencing frequent
exacerbations and significant limitations on lung function and
quality of life. Severe, uncontrolled asthma has higher risk of
mortality than severe asthma.
Severe, uncontrolled asthma can lead to a dependence on OCS,
with systemic steroid exposure potentially leading to serious
short- and long-term adverse effects including weight gain,
diabetes, osteoporosis, glaucoma, anxiety, depression,
cardiovascular disease and immunosuppression. There is also a
significant physical and socio-economic burden of severe,
uncontrolled asthma with these patients accounting for 50% of
asthma-related costs despite compromising only 10% of the asthma
population.
Clinical features associated with an eosinophilic phenotype that
can act as markers for enhanced efficacy with targeted therapy in
severe eosinophilic asthma include: greater baseline blood
eosinophil counts, a history of more frequent exacerbations,
chronic OCS use and a history of nasal polyposis.
About FASENRA
FASENRA is a monoclonal antibody that binds directly to the
IL-5α receptor on eosinophils, and attracts natural killer cells to
induce rapid and near-complete depletion of eosinophils via
apoptosis (programmed cell death). Eosinophils are a type of white
blood cell that are a normal part of the body's immune system and
elevated levels of eosinophils are seen in about half of severe
asthma patients. Elevated levels of eosinophils impact airway
inflammation and airway hyper-responsiveness, resulting in
increased asthma severity and symptoms, decreased lung function and
increased risk of exacerbations.
FASENRA is AstraZeneca’s first respiratory biologic, now
approved as an add-on treatment in severe eosinophilic asthma in
the US, EU, Japan, and several other countries, and under
regulatory review in several other jurisdictions. Where
approved, FASENRA is available as a fixed-dose
subcutaneous injection via a prefilled syringe administered once
every 4 weeks for the first 3 doses, and then once every 8 weeks
thereafter.
FASENRA was developed by AstraZeneca with MedImmune, the
company’s global biologics research and development arm, and is
in-licensed from BioWa, Inc., a wholly-owned subsidiary of Kyowa
Hakko Kirin Co., Ltd., Japan.
About the BORA Trial
BORA is one of the six Phase III trials in the FASENRA WINDWARD
program in asthma, which also includes SIROCCO, CALIMA, ZONDA, BISE
and GREGALE. BORA is a randomized, double-blind, parallel-group,
Phase III extension trial of patients who had completed one of the
three pivotal Phase III trials, SIROCCO, CALIMA or ZONDA. The
current analysis includes results for 1926 patients from the two
placebo controlled exacerbation trials, SIROCCO (48 week) and
CALIMA (56 week). Patients continued add-on treatment with
subcutaneous FASENRA 30 mg every 4 weeks (Q4W) or every 8 weeks
(Q8W; first three doses 4 weeks apart) or, for patients previously
receiving placebo, were re-randomized 1:1 to either Q4W or Q8W.
Once the BORA target enrollment had been achieved, adult
patients who wanted to continue treatment for a longer period of
time had the option to continue therapy in an additional
open-label, long term extension trial, without completing the full,
planned follow up in BORA. Approximately half of patients in the
shorter (28 weeks) and smaller ZONDA study went into an additional
extension trial without completing the planned 56-week treatment
period in BORA. Therefore, ZONDA patients were not included in this
BORA analysis, and will be reported separately according to the
analysis plan.
Additional analyses from the BORA trial, including treatments in
adolescents up to 108 weeks, will be available in the second half
of 2019.
About AstraZeneca in Respiratory Disease
Respiratory disease is one of AstraZeneca’s main therapy areas,
and the Company has a growing portfolio of medicines that reached
more than 18 million patients in 2017. AstraZeneca’s aim is to
transform asthma and COPD treatment through inhaled combinations at
the core of care, biologics for the unmet needs of specific patient
populations, and scientific advancements in disease
modification.
The Company is building on a 40-year heritage in respiratory
disease and AstraZeneca’s capability in inhalation technology spans
pressurized metered-dose inhalers and dry powder inhalers, as well
as the AEROSPHERE™ Delivery Technology. The Company also has a
growing portfolio of respiratory biologics including FASENRA
(anti-IL-5rɑ), now approved for severe eosinophilic asthma and in
development for severe nasal polyposis, and tezepelumab
(anti-TSLP), which is in Phase III trials and achieved its Phase
IIb primary and secondary endpoints. AstraZeneca’s research is
focused on addressing underlying disease drivers focusing on the
lung epithelium, lung immunity and lung regeneration.
About AstraZeneca
AstraZeneca is a global, science-led biopharmaceutical company
that focuses on the discovery, development and commercialization of
prescription medicines, primarily for the treatment of diseases in
three main therapy areas - Oncology, Cardiovascular, Renal &
Metabolism and Respiratory. The Company also is selectively active
in the areas of autoimmunity, neuroscience and infection.
AstraZeneca operates in over 100 countries and its innovative
medicines are used by millions of patients worldwide. For more
information, please visit www.astrazeneca-us.com and follow us on
Twitter @AstraZenecaUS.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20180918005171/en/
Media InquiriesAstraZenecaMichele Meixell +1
302-885-2677orAbigail Bozarth +1 302-885-2677
AstraZeneca (NYSE:AZN)
Historical Stock Chart
From Mar 2024 to Apr 2024
AstraZeneca (NYSE:AZN)
Historical Stock Chart
From Apr 2023 to Apr 2024